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Launch Digital Edition

Webinars and Sponsored Roundtables — Register Now

Tuesday, June 9, 2026, 1:00–2:00 PM ET
In this webinar, we will examine how immune recognition after allogeneic HCT can influence leukemia relapse and disease progression. The session will highlight the clinical relevance of HLA loss of heterozygosity (LOH), approaches used for its detection, and how LOH findings may support transplant strategies, including considerations for donor selection in subsequent transplantation.

Webinar presenter Alberto Cardoso Martins Lima, PhD, Clinical consulting scientist in histocompatibility,
specializing in allogeneic hematopoietic cell transplantation (HCT) at IGEN/AFIP São Paulo and CHC/UFPR in Curitiba, Brazil

Moderated by: Bob McGonnagle, Publisher, CAP TODAY

Register Now

Wednesday, June 24, 2026, 12:00–1:00 PM ET
Hear an expert discuss the expanded clinical utility of HER2 IHC scoring in metastatic breast cancer and its impact on your practice

Webinar presenter Michelle Shiller, DO, AP, CP, MGP, FACP, Baylor University Medical Center.

Moderated by: Bob McGonnagle, Publisher, CAP TODAY

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Wednesday, July 15, 2026, 1:00-2:00 PM ET
Hear an expert discuss how to integrate Kappa and Lambda in situ hybridization testing into your standard hematopathology workflow to accurately assess B-cell and plasma cell clonality. You will also gain the skills to recognize testing pitfalls in challenging reactive versus neoplastic proliferations and apply ancillary tools to resolve complex cases.

Webinar presenter Xiaojun Wu, MD, PhD, Assistant professor, Director of Hematopathology Section at NCR of Johns Hopkins Medicine Department of Pathology, SOM at Johns Hopkins University

Moderated by: Bob McGonnagle, Publisher, CAP TODAY

Register Now

Subspecialties

Interactive Product Guides

Marketplace

MMQCI launches BCR-ABL1, hereditary hemochromatosis controls

January 2025—Maine Molecular Quality Controls announced the launch of the Birlinn BCR-ABL1 p210 IS panel C230, intended to monitor the detection and quantification of BCR-ABL1 (p210) fusion gene using molecular test systems. The panel, with assigned values traceable to the World Health Organization, allows calculation of a conversion factor necessary to express quantification results (M-bcr transcript of BCR-ABL1 p210 relative to the ABL1 transcript) according to the International Scale. The company also launched the Birlinn BCR-ABL1 p210 IS control panel C240, intended for use as an assayed external quality control to monitor the performance of in vitro laboratory nucleic acid detection and quantification of BCR-ABL1 (p210) fusion gene.

BioFire tropical fever panel gets special 510(k) clearance

January 2025—BioMérieux announced that its BioFire Film­Array Tropical Fever panel has received FDA special 510(k) clearance. The panel is capable of testing chikungunya, dengue (serotypes 1, 2, 3, and 4), Leptospira, Plasmodium species, Plasmodium falciparum, and Plasmodium vivax/ovale and has a run time of about 50 minutes on the fully automated BioFire FilmArray 2.0 and Torch systems. Sample prep time is two minutes.

BD, Babson expand access to fingertip blood testing

January 2025—BD and Babson Diagnostics announced an expansion of fingertip blood collection and testing technologies for use by U.S. health systems and other large provider networks in settings like urgent cares, doctors’ offices, and other ambulatory care settings. The blood testing process integrates BD’s MiniDraw capillary blood collection system with Babson’s BetterWay technologies to enable test results from as few as six drops of capillary blood collected from a patient’s finger. Samples can be collected and prepared by any trained health care worker, including those without prior phlebotomy experience.

Thermo Fisher gets clearance for TaqPath COVID-19 PCR kit

January 2025—Thermo Fisher Scientific has received FDA 510(k) clearance for the Applied BioSystems TaqPath COVID-19 diagnostic PCR kit. The kit was first introduced as an EUA test; the 510(k) clearance allows clinical and public health laboratories to convert to an in vitro diagnostic workflow. The kit is intended for use with nasopharyngeal and anterior nasal swab samples and includes assays and controls for the real-time PCR detection of RNA from SARS-CoV-2 emerging virus.

Tempus AI to acquire Ambry Genetics

January 2025—Tempus AI announced it has entered into an agreement to acquire Ambry Genetics. Under the terms of the agreement, Tempus will pay $375 million in cash and $225 million in shares at closing, of which $100 million will be subject to a lock-up agreement until one year post-transaction close. Ambry expects to generate more than $300 million in revenue in 2024 and earnings before interest, taxes, depreciation, and amortization of more than $40 million.

Thermo Fisher, Mainz Biomed to develop a next-gen CRC screening test

January 2025—Mainz Biomed, a Germany-based molecular genetics diagnostic company specializing in cancer diagnostics, announced a collaborative agreement with Thermo Fisher Scientific, through its subsidiary Life Technologies Corp. The companies will jointly develop and potentially commercialize Mainz Biomed’s next-generation colorectal cancer screening product. The test targets the early detection of colorectal cancer and focuses on precancerous lesions, particularly advanced adenomas.

Study finds Aspyre Lung is a rapid, low-input solution for NSCLC testing

January 2025—Biofidelity announced the publication of data that highlight how Aspyre technology addresses the need for rapid, accessible molecular diagnostics informing actionable genomic variants in cancer (Herlihy SE, et al. Transl Lung Cancer Res. 2024;13[11]:3083–3095). The study demonstrates that Aspyre Lung reagents can be easily set up and run at external laboratories within a few days, producing reliable results even from challenging sample types.

UllCore BSI test gets breakthrough device designation

January 2025—Deepull announced it has received breakthrough device designation from the FDA for its UllCore bloodstream infection test. The test detects 95 percent of pathogens associated with bloodstream infections that may lead to sepsis, as well as select genetic determinants of antimicrobial resistance, and has a turnaround time of one hour. The real-time multiplex PCR system extracts and analyzes total microbial DNA from 8 mL of whole blood.

RightBio Metrics gastric pH indicators

January 2025—RightBio Metrics has announced the availability of its RightSpot Gastric pH Indicators. The FDA-cleared, CLIA-waived product uses pH to confirm gastric acidity for tubes intended to end in the stomach. Other than an x-ray, the primary identifier of a properly placed nasogastric or orogastric tube tip, RightBio says, is a pH reading of 5.5 or less. Each indicator is individually packaged in high-density copolymer foil with proprietary surface treatment to prevent air, light, and humidity from penetrating and can be stored at temperatures between -40°C and 52°C.

QIAstat-Dx instruments, assays get IVDR certification

January 2025—Qiagen announced that its QIAstat-Dx syndromic testing systems and associated assays have received CE marking under the European Union in vitro diagnostic medical devices regulation. The certification includes the QIAstat-Dx analyzer, QIAstat-Dx Rise, and panels for detecting gastrointestinal and respiratory illnesses. The submission for IVDR certification of the QIAstat-Dx meningitis/encephalitis panel is expected in the coming months. The company is transitioning more than 180 products to the IVDR framework.

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